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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Sr. Director / Executive Director - Safety Data Scientist

Purpose:

The purpose of the Sr. Director / Executive Director - Safety Data Scientist role is to provide strategic leadership for the technology, systems, automation, and analytics strategy across Global Patient Safety, globally. The Sr. Director / Executive Director will work in close collaboration with the Sr Director/ Executive Director - Safety Data Sciences Leader, the GPS Data Sciences Team, and Global Patient Safety (GPS) leadership team to drive awareness, alignment and input to the technology, automation, and systems strategy for all functional areas in GPS. The Sr. Director / Executive Director Safety Data Scientist provides strategy, oversight, and expertise for the GPS systems, technologies, and associated processes involved in the management of safety information, including creation, assessment, implementation, and maintenance of those activities.

Leadership of Technology, Systems, Automation and Analytics Strategy

+ Owns automation, technology, and analytics strategies for GPS and understand linkage to functions within and outside of GPS that ensures adequate input, influence, and efficient implementation.

+ Benchmark automation and process efficiency efforts within and outside of Eli Lilly and apply to GPS.

+ Identify, lead, and support process improvement efforts that drive tangible efficiency and productivity results for GPS.

+ Build business technology capabilities and skills to support GPS future state.

Strategic and Technical Leadership

+ Providing system and associated business process leadership to ensure information management tools and associated processes are adequately designed, developed, revised, maintained, and fully documented and communicated to enable compliance, in an environment of continuous and disparate regulatory changes worldwide including:

+ Responsible for the development of new business processes and maintenance of existing system tools, technologies, and strategies in support of related business processes within GPS

+ Accountable for creation and maintenance of system process maps

+ Update and revise information management tools and associated processes in a timely manner to ensure they are consistent and compliant with applicable regulatory requirements

+ Lead the development of new systems and associated processes when required based either on new or revised regulations or guidelines or on an internal assessment of the capabilities of GPS

+ Consult to ensure new and existing tools (e.g. LSS, Business Objects, Tableau) to support and enable the GPS processes.

+ Influence leadership and share best practices in system and associated business process execution and development with cross functional teams within MDU, the BUs and affiliates globally

+ Work with partners both internal and external to Lilly involved in or affected by the systems and associated processes

+ Oversee and review standard operating procedures (SOPs), ensure SOPs fully describe current practices and are in line with current regulations and guidance

+ Provide subject matter expertise including integration of information regarding any new global regulations and guidance impacting systems, information management strategies, and those processes

+ Ensure that training is in place to ensure all staff are fully trained and appropriately qualified for the systems and associated implementation of processes

+ Interact, educate, facilitate, and influence both tactics and strategy across multiple functions within GPS and throughout the MDU, BUs, Global Affiliates, and alliance partners to ensure compliance in the face of continual evolution of regulatory requirements

+ Work with the Medicines Quality Organization (MQO) network to ensure compliance and adhere to required timelines for submission of right to operate documents

+ Educate and monitor the deliverables required from personnel in functions within the MDU, BUs and Global Affiliates as well as alliance partners who are not well versed in or experienced with the requirements for regulatory compliance and who are subject to considerable turnover within and between regulatory reporting cycles

+ Monitor and evaluate global and affiliate compliance trends to identify deviations and root cause patterns to inform process improvements

Company Presence/ Influence (Internal/external related to GPS Systems)

+ Build effective relationships within GPS to facilitate system and related process understanding, acceptance and execution Serve to elevate the profile of GPS and the science of pharmacovigilance as an essential obligation of the company by establishing a visible presence and productive relationships and collaborations with other functions

+ These collaborations will include leadership of multiple global and regional groups, including but not limited to GPS Medical and Benefit-Risk Management, GPS Pharmacoepidemiology, GPS Clinical Case Management, MQO, GPS Tech@Lilly, GPS senior management, the EU QPPV/DQPPV, Global BU Medical, regional/affiliate BU Medical, other MDU Functions, Clinical Development (early and late phase), Regulatory Affairs – North America and International, regional/affiliate brand teams, and alliance partners

+ Represent and influence GPS requirements and policy on safety management to internal and external stakeholders and identify opportunities for improving policies and regulations related to safety management

+ Provide expert support and coordination for safety inspections and audits, including support and coordination of required responses.

+ Exercise broad external influence with regulators and the broader pharmacovigilance community by providing input on critiques of draft guidance and by sharing Lilly implementation processes Respond to requests from regulatory authorities for consultation on Lilly’s pharmacovigilance and risk management processes

Understanding and Support of the Qualified Person for Pharmacovigilance (QPPV) role

+ Understanding the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance

+ Ensure support is provided to enable the Qualified Person to fulfill all legal responsibilities as required by existing and new regulatory requirements

Training, Coaching, Mentoring

+ Provide training, coaching and mentorship to GPS personnel as needed or requested on the execution of safety management systems and related processes both inside and outside of GPS

+ Train and inform functional leaders in the MDU, BUs, Affiliates and alliance partners on GPS systems and associated processes essential to compliance so they can provide coaching within their areas to ensure implementation of these systems and associated processes as necessary.

Minimum Qualification Requirements:

+ Bachelor’s degree within a health science, Information Management, Mathematics, Statistics, Computer Science field.

+ 5 years of experience, supporting drug development areas (e.g., Safety, Clinical, Project Management, etc.).

Other Information/Additional Preferences:

+ Experience in Pharmacovigilance/Clinical/Regulatory systems, technologies and associated processes for which the individual will have responsibility (e.g. Argus, Empirica, RxLogix Safety Suite, etc.)

+ Demonstrated strategic thinking skills and driving broad change.

+ Process Management experience and exceptional project management skills.

+ Strong oral and written communication skills

+ Strong leadership and interpersonal skills, ability to influence across multiple functions and regions and be able to work independently and as a team member on a variety of issues.

+ Ability to effectively coach and mentor individuals inside and outside of GPS on the day-to-day activities associated with execution of the business process.

+ Demonstrated success in managing large, multi-component projects.

+ Ability to work in a global environment with external focus.

+ Availability to travel when required.

+ Expertise in Pharmacovigilance

+ Prior systems ownership, systems implementation.

+ Demonstrated application of process automation and analytics cross-functionally.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$151,500 - $222,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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